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This clinical utility study pilot is based on a review of real but de-identified and randomized patient cases and aims to evaluate Urologists' treatment recommendations before and after reviewing the results provided by the Decipher test. This is a pilot study and the primary intent is to help guide development and design of future clinical utility studies for Decipher
The primary and secondary objectives will be assessed in retrospectively selected prostate cancer patients treated with radical prostatectomy with one or more adverse pathological features (APFs)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Practicing urologic surgeons | Performing at least 60 radical prostate surgeries annually |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DECIPHER Questionnaire | Other | Participants are asked to complete a questionnaire to assess the impact of Decipher on physicians' treatment recommendation. All participants use the same data collection instrument. Each participant opinion is collected based on a random selection of cases. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in treatment recommendation | To determine the extent to which the use of the Decipher test influences treatment recommendations by physicians post radical prostatectomy (RP). This decision impact study aims to evaluate Urologists' treatment recommendations before and after reviewing the results provided by the Decipher test. | 1.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Urologist's perception regarding the utility of the Decipher |
| 1.5 years |
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Criteria (Participant enrollment)
Inclusion Criteria Study participants:
Exclusion Criteria Study Participants:
(1) Did not meet the inclusion criteria
Criteria (Case selection)
Inclusion Criteria Case File:
Patient cases eligible for this study were treated with radical prostatectomy and have one or more adverse pathological features present defined as:
Pathological Gleason score >= 8 or Gleason score 7 with primary pattern 4; Pathological stage T3A (= Extraprostatic extension) or T3B (=Seminal vesicle invasion); Positive surgical margins Gleason grade upgrade from biopsy to surgery
Exclusion Criteria Case File:
Metastatic disease (M+) prior to surgery Received any neo-adjuvant prostate cancer treatment with radical prostatectomy (radiation, hormone, chemotherapy)
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This is an exploratory study utilizing archived tumor specimens and demographic and pathologic characteristics derived from the patient's medical charts. The study participants are the urologists who review the selected case files.
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| Name | Affiliation | Role |
|---|---|---|
| Elai Davicioni, pHd | GenomeDx Biosciences Inc. | Principal Investigator |
| Badani Ketan, MD | Department of Urology, Columbia University, New York, NY USA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GenomeDx Bioscience Inc. | San Diego | California | 92121 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23592338 | Result | Badani K, Thompson DJ, Buerki C, Davicioni E, Garrison J, Ghadessi M, Mitra AP, Wood PJ, Hornberger J. Impact of a genomic classifier of metastatic risk on postoperative treatment recommendations for prostate cancer patients: a report from the DECIDE study group. Oncotarget. 2013 Apr;4(4):600-9. doi: 10.18632/oncotarget.918. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |